ong-term Outcome of Children Enrolled in Study ROPP-2008-01 Previously Treated with rhIGF-1/rhIGFBP-3 for the Prevention of Retinopathy of Prematurity (ROP) or Who Received Standard Neonatal Care

Phase 1

• Conditions: Retinopathy of Prematurity (ROP); Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

• Registration Number: EUCTR2014-003556-31-PL
• Lead Sponsor: Premacure AB, A Member of the Shire Group of Companies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-21
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Each subject must meet the following criteria to be enrolled in this study.
1. Subject was randomized in Study ROPP-2008-01, Section D
2. Subject’s parent or legally authorized representative(s) must provide written informed consent prior to performing any study-related activities. Study-related activities are any procedures that would not have been performed during normal management of the subject.
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from the study.
1. Any other condition or therapy that, in the Investigator’s opinion, may pose a risk to the
subject or interfere with the subject’s ability to be compliant with this protocol or interfere
with the interpretation of results
2. The subject or subject’s parent or legally authorized representative(s) is unable to comply
with the protocol as determined by the Investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified